NCT01233570已完成2 期
Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment
研究概览
简要总结
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willingness and capability to follow the study procedure
- •confirmed diagnosis of Crohn's Disease of at least 3 months duration confirmed by radiography, endoscopy or pathological examination
- •required to have a skin manifestation of Crohn's disease
- •required to give written informed consent
- •both male and female subjects with reproductive potential required to be on an acceptable form of birth control for the duration of the study
- •long-standing, concomitant immunosuppressive therapy was allowed if the dose was stable and not controlling the skin problem
排除标准
- •known sensitivity to tacrolimus
- •change in aminosalicylate dosage in the four weeks prior to screening
- •on oral steroids at over 40mg per day
- •been commenced on methotrexate, azathoprine or ciclosporin within the last two months
- •commenced on a a TNF-alpha monoclonal antibody within the three months prior to screening
- •patients having had a stoma fashioned less than three months before enrolment
- •patients with an immunocompromising disease
- •patients with a diagnosis of malignancy within the last five years
- •patients with any other condition, past or present treatment thought by the investigator to render the subject ineligible for the study
研究组 & 干预措施
Topical tacrolimus
Experimental
Once daily topical application
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment
时间窗: At 12 weeks of treatment, optionally extended to 52 weeks
次要结局
- Global Self Assessment(12 weeks, optionally extended to 52 weeks)
- Perineal Disease Activity Index(12 weeks, optionally extended to 52 weeks)
研究者
研究点 (1)
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